81 FR 3431 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 13 (January 21, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 13 (January 21, 2016)
| Page Range | 3431-3432 | |
| FR Document | 2016-01165 |
[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)] [Notices] [Pages 3431-3432] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01165] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues. Date and Time: The meeting will be held on February 16, 2016 from 1 p.m. to 5 p.m. Location: FDA White Oak Conference Center, rm 1503. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. Contact Person: Janie Kim or Rosanna Harvey, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, 301-796-9016 or 240-402-8072, [email protected] or [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On February 16, 2016, the committee will meet by teleconference. In open session, the committee will hear updates of research programs in the Tumor Vaccines and Biotechnology Branch and the Cellular and Tissue Therapy Branch of the Division of Cellular and Gene Therapies, Office of Cellular, Tissue and Gene Therapy, Center for Biologics Evaluation and Research, FDA. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: On February 16, 2016, from 1:00 p.m. to 3:55 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before February 1, 2016. Oral presentations from the public will be scheduled between approximately 2:55 p.m. to 3:55 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 22, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by January 25, 2016. Closed Committee Deliberations: On February 16, 2016, from 3:55 p.m. to 5:00 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of intramural research programs and make recommendations regarding personnel staffing decisions. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Janie Kim at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/ AdvisoryCommittees/ [[Page 3432]] AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 15, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016-01165 Filed 1-20-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices 3431
Application No. Drug Applicant
ANDA 062436 .... T–STAT (erythromycin) Solution; Topical, 2% .......................................................................... Westwood-Squibb Pharma-
ceuticals, Inc.
ANDA 080439 .... CHLORPROMAZINE HCl (chlorpromazine HCl) Tablet; Oral, 10 mg; 25 mg; 50 mg; 100 Sandoz Inc.
mg; 200 mg.
FDA has reviewed its records and, Date and Time: The meeting will be AdvisoryCommittees/Calendar/
under § 314.161, has determined that held on February 16, 2016 from 1 p.m. default.htm. Scroll down to the
the drug products listed in this to 5 p.m. appropriate advisory committee meeting
document were not withdrawn from Location: FDA White Oak Conference link.
sale for reasons of safety or Center, rm 1503. Answers to commonly Procedure: On February 16, 2016,
effectiveness. Accordingly, the Agency asked questions including information from 1:00 p.m. to 3:55 p.m., the meeting
will continue to list the drug products regarding special accommodations due is open to the public. Interested persons
listed in this document in the to a disability, visitor parking, and may present data, information, or views,
‘‘Discontinued Drug Product List’’ transportation may be accessed at: orally or in writing, on issues pending
section of the Orange Book. The http://www.fda.gov/ before the committee. Written
‘‘Discontinued Drug Product List’’ AdvisoryCommittees/ submissions may be made to the contact
identifies, among other items, drug AboutAdvisoryCommittees/ person on or before February 1, 2016.
products that have been discontinued ucm408555.htm. Oral presentations from the public will
from marketing for reasons other than Contact Person: Janie Kim or Rosanna be scheduled between approximately
safety or effectiveness. Harvey, Center for Biologics Evaluation 2:55 p.m. to 3:55 p.m. Those individuals
Approved ANDAs that refer to the and Research, Food and Drug interested in making formal oral
NDAs and ANDAs listed in this Administration, 10903 New Hampshire presentations should notify the contact
document are unaffected by the Ave., Bldg. 71, Silver Spring, MD person and submit a brief statement of
discontinued marketing of the products 20993–0002, 301–796–9016 or 240– the general nature of the evidence or
subject to those NDAs and ANDAs. 402–8072, janie.kim@fda.hhs.gov or arguments they wish to present, the
Additional ANDAs that refer to these Rosanna.Harvey@fda.hhs.gov, or FDA names and addresses of proposed
products may also be approved by the Advisory Committee Information Line, participants, and an indication of the
Agency if they comply with relevant 1–800–741–8138 (301–443–0572 in the approximate time requested to make
legal and regulatory requirements. If Washington, DC area). A notice in the their presentation on or before January
FDA determines that labeling for these Federal Register about last minute 22, 2016. Time allotted for each
drug products should be revised to meet modifications that impact a previously presentation may be limited. If the
current standards, the Agency will announced advisory committee meeting number of registrants requesting to
advise ANDA applicants to submit such cannot always be published quickly speak is greater than can be reasonably
labeling. enough to provide timely notice. accommodated during the scheduled
Therefore, you should always check the open public hearing session, FDA may
Dated: January 14, 2016.
Agency’s Web site at http:// conduct a lottery to determine the
Leslie Kux,
www.fda.gov/AdvisoryCommittees/ speakers for the scheduled open public
Associate Commissioner for Policy. default.htm and scroll down to the hearing session. The contact person will
[FR Doc. 2016–01097 Filed 1–20–16; 8:45 am] appropriate advisory committee meeting notify interested persons regarding their
BILLING CODE 4164–01–P link, or call the advisory committee request to speak by January 25, 2016.
information line to learn about possible Closed Committee Deliberations: On
modifications before coming to the February 16, 2016, from 3:55 p.m. to
DEPARTMENT OF HEALTH AND meeting. 5:00 p.m., the meeting will be closed to
HUMAN SERVICES Agenda: On February 16, 2016, the permit discussion where disclosure
committee will meet by teleconference. would constitute a clearly unwarranted
Food and Drug Administration In open session, the committee will hear invasion of personal privacy (5 U.S.C.
[Docket No. FDA–2016–N–0001] updates of research programs in the 552b(c)(6)). The committee will discuss
Tumor Vaccines and Biotechnology reports of intramural research programs
Cellular, Tissue and Gene Therapies Branch and the Cellular and Tissue and make recommendations regarding
Advisory Committee; Notice of Meeting Therapy Branch of the Division of personnel staffing decisions.
AGENCY: Food and Drug Administration, Cellular and Gene Therapies, Office of Persons attending FDA’s advisory
HHS. Cellular, Tissue and Gene Therapy, committee meetings are advised that the
Center for Biologics Evaluation and Agency is not responsible for providing
ACTION: Notice.
Research, FDA. access to electrical outlets.
This notice announces a forthcoming FDA intends to make background FDA welcomes the attendance of the
meeting of a public advisory committee material available to the public no later public at its advisory committee
of the Food and Drug Administration than 2 business days before the meeting. meetings and will make every effort to
(FDA). At least one portion of the If FDA is unable to post the background accommodate persons with disabilities.
asabaliauskas on DSK9F6TC42PROD with NOTICES
meeting will be closed to the public. material on its Web site prior to the If you require accommodations due to a
Name of Committee: Cellular, Tissue meeting, the background material will disability, please contact Janie Kim at
and Gene Therapies Advisory be made publicly available at the least 7 days in advance of the meeting.
Committee. location of the advisory committee FDA is committed to the orderly
General Function of the Committee: meeting, and the background material conduct of its advisory committee
To provide advice and will be posted on FDA’s Web site after meetings. Please visit our Web site at
recommendations to the Agency on the meeting. Background material is http://www.fda.gov/
FDA’s regulatory issues. available at http://www.fda.gov/ AdvisoryCommittees/
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![3432 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices
AboutAdvisoryCommittees/ U.S.C. 360ccc(h)) the conditional availability of the guidance entitled
ucm111462.htm for procedures on approval is no longer in effect. ‘‘Implanted Blood Access Devices for
public conduct during advisory AB Science, 3 Avenue George V, Hemodialysis.’’ This guidance was
committee meetings. 75008 Paris, France, filed an application developed to support the
Notice of this meeting is given under for conditional approval (141–308) that reclassification of the implanted blood
the Federal Advisory Committee Act (5 provided for veterinary prescription use access devices for hemodialysis into
U.S.C. app. 2). of KINAVET–CA1 (masitinib mesylate) class II (special controls) and to assist
Dated: January 15, 2016. Tablets for the treatment of recurrent industry in preparing premarket
Jill Hartzler Warner, (post-surgery) or nonresectable Grade II notification (510(k)) submissions for
or III cutaneous mast cell tumors in dogs implanted blood access devices for
Associate Commissioner for Special Medical
Programs. that have not previously received hemodialysis.
[FR Doc. 2016–01165 Filed 1–20–16; 8:45 am]
radiotherapy and/or chemotherapy DATES: Submit either electronic or
except corticosteroids. That application written comments on this guidance at
BILLING CODE 4164–01–P
was conditionally approved on any time. General comments on Agency
December 15, 2010. guidance documents are welcome at any
DEPARTMENT OF HEALTH AND On December 15, 2014, application time.
HUMAN SERVICES 141–308 received the fourth and final ADDRESSES: You may submit comments
renewal of its conditional approval. as follows:
Food and Drug Administration That final renewal terminated on
December 15, 2015. As of that date, FDA Electronic Submissions
[Docket No. FDA–2015–N–0002]
did not approve an NADA for Submit electronic comments in the
Conditional Approval of a New Animal KINAVET–CA1 under section 512 of the following way:
Drug No Longer In Effect; Masitinib FD&C Act. Consequently, as of • Federal eRulemaking Portal: http://
Mesylate Tablets December 15, 2015, the conditional www.regulations.gov. Follow the
approval of application 141–308 is no instructions for submitting comments.
AGENCY: Food and Drug Administration, longer in effect. Comments submitted electronically,
HHS. Because the conditional approval is including attachments, to http://
ACTION:Notice of conditional approval no longer in effect, KINAVET–CA1 www.regulations.gov will be posted to
no longer in effect. Tablets is now an unapproved new the docket unchanged. Because your
animal drug product with no legal comment will be made public, you are
SUMMARY: The Food and Drug marketing status. Further marketing, solely responsible for ensuring that your
Administration (FDA) is providing sales, and distribution of the product are comment does not include any
notice that the conditional approval of illegal. confidential information that you or a
an application for masitinib mesylate This notice is issued under section third party may not wish to be posted,
tablets, a new animal drug for a minor 571 of the FD&C Act and under such as medical information, your or
use, is no longer in effect. authority delegated to the Commissioner anyone else’s Social Security number, or
DATES: Conditional approval is no of Food and Drugs and redelegated to confidential business information, such
longer in effect as of December 15, 2015. the Center for Veterinary Medicine. as a manufacturing process. Please note
FOR FURTHER INFORMATION CONTACT: Elsewhere in this issue of the Federal that if you include your name, contact
Herman M. Schoenemann III, Center for Register, FDA is amending the animal information, or other information that
Veterinary Medicine (HFV–108), Food drug regulations to reflect that the identifies you in the body of your
and Drug Administration, 7500 Standish conditional approval of an application comments, that information will be
Pl., Rockville, MD 20855, 240–402– for this new animal drug is no longer in posted on http://www.regulations.gov.
0652, herman.schoenemann@ effect. • If you want to submit a comment
fda.hhs.gov. with confidential information that you
Dated: January 14, 2016. do not wish to be made available to the
SUPPLEMENTARY INFORMATION: The Bernadette Dunham, public, submit the comment as a
Federal Food, Drug, and Cosmetic Act Director, Center for Veterinary Medicine. written/paper submission and in the
(FD&C Act), as amended by the Minor [FR Doc. 2016–01104 Filed 1–20–16; 8:45 am] manner detailed (see ‘‘Written/Paper
Use and Minor Species Animal Health
BILLING CODE 4164–01–P Submissions’’ and ‘‘Instructions’’).
Act of 2004 (Pub. L. 108–282), permits
conditional approval of new animal Written/Paper Submissions
drugs for minor uses. Conditional DEPARTMENT OF HEALTH AND Submit written/paper submissions as
approval of a new animal drug is HUMAN SERVICES follows:
effective for a 1-year period, and may be • Mail/Hand delivery/Courier (for
renewed for up to four additional 1-year Food and Drug Administration written/paper submissions): Division of
periods. The holder of a conditionally Dockets Management (HFA–305), Food
approved new animal drug is required [Docket No. FDA–2013–D–0749]
and Drug Administration, 5630 Fishers
to submit all information necessary to Lane, Rm. 1061, Rockville, MD 20852.
Implanted Blood Access Devices for
support a complete new animal drug
Hemodialysis; Guidance for Industry • For written/paper comments
application (NADA) under section submitted to the Division of Dockets
asabaliauskas on DSK9F6TC42PROD with NOTICES
and Food and Drug Administration
512(b)(1) of the FD&C Act (21 U.S.C. Management, FDA will post your
Staff; Availability
360b(b)(1) by 180 days before the comment, as well as any attachments,
termination of the fifth 1-year period of AGENCY: Food and Drug Administration, except for information submitted,
conditional approval. If FDA does not HHS. marked and identified, as confidential,
approve an NADA for the new animal ACTION: Notice of availability. if submitted as detailed in
drug by the termination date of the ‘‘Instructions.’’
conditional approval, then pursuant to SUMMARY: The Food and Drug Instructions: All submissions received
section 571(h) of the FD&C Act (21 Administration (FDA) is announcing the must include the Docket No. FDA–
VerDate Sep<11>2014 18:26 Jan 20, 2016 Jkt 238001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\21JAN1.SGM 21JAN1](https://thefederalregister.org/doc/81_FR_3444/page/2.svg)
Document Created: 2018-02-02 12:34:10
Document Modified: 2018-02-02 12:34:10
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| FR Citation | 81 FR 3431 |
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